Mingyu Chen1,2, Jiasheng Cao1, Diyu Huang1, Bin Zhang1, Long Pan1, Zhongtao Zhang3, Zhenjun Wang4, Yingjiang Ye5, Dianrong Xiu6, Dechuan Li7, Xiujun Cai8,9. 1. Department of General Surgery, Sir Run-Run Shaw Hospital, Zhejiang University, No.3 East Qingchun Road, Hangzhou, 310016, China. 2. Key Laboratory of Endoscopic Technique Research of Zhejiang Province, Sir Run-Run Shaw Hospital, Zhejiang University, Hangzhou, 310016, China. 3. Department of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, 100032, China. 4. Department of Anorectal Surgery, Beijing Chao-yang Hospital, Capital Medical University, Beijing, 100020, China. 5. Department of Gastrointestinal Surgery, Peking University People's Hospital, Beijing, 100032, China. 6. Department of General Surgery, Peking University Third Hospital, Beijing, 100089, China. 7. Department of Colorectal Surgery, Zhejiang Cancer Hospital, Hangzhou, 310011, China. 8. Department of General Surgery, Sir Run-Run Shaw Hospital, Zhejiang University, No.3 East Qingchun Road, Hangzhou, 310016, China. srrsh_cxj@zju.edu.cn. 9. Key Laboratory of Endoscopic Technique Research of Zhejiang Province, Sir Run-Run Shaw Hospital, Zhejiang University, Hangzhou, 310016, China. srrsh_cxj@zju.edu.cn.
Abstract
PURPOSE: Our animal studies have demonstrated the safety and feasibility of end-to-end intestinal anastomosis using a stent for laparoscopic colonic surgery. Therefore, we designed a non-inferiority trial to investigate the outcomes of stent anastomosis (SA) vs. those of conventional hand-sewn anastomosis (CA). METHODS: A multicenter randomized controlled trial was conducted between December, 2016 and April, 2018. The primary outcome was the healing condition of the anastomoses, evaluated by endoscopy 6 months postoperatively. The secondary outcomes were the anastomotic completion time, anastomotic leak, intestinal obstruction, peritoneal effusion, and bleeding. Quality of life (QOL) was evaluated by questionnaires. RESULTS: The subjects of this study were 60 patients, randomly divided into a SA group (n = 30) and a CA group (n = 30). There were no differences in anastomotic healing conditions (P = 1.00). The stent procedure was associated with a significantly shorter anastomosis time than the hand-sewn anastomosis (13.517 ± 4.281 vs. 20.333 ± 2.998 min, respectively; P < 0.001). There were no significant differences in anastomotic leakage, intestinal obstruction, peritoneal effusion, or bleeding between the groups. Questionnaires revealed almost no discrepancy between baseline QOL scores and those assessed 2, 4, 8, 12, and 24 weeks postoperatively in either group. CONCLUSIONS: Intestinal anastomosis with a stent is a non-inferior strategy for laparoscopic colonic surgery, which requires less time for the anastomosis.
RCT Entities:
PURPOSE: Our animal studies have demonstrated the safety and feasibility of end-to-end intestinal anastomosis using a stent for laparoscopic colonic surgery. Therefore, we designed a non-inferiority trial to investigate the outcomes of stent anastomosis (SA) vs. those of conventional hand-sewn anastomosis (CA). METHODS: A multicenter randomized controlled trial was conducted between December, 2016 and April, 2018. The primary outcome was the healing condition of the anastomoses, evaluated by endoscopy 6 months postoperatively. The secondary outcomes were the anastomotic completion time, anastomotic leak, intestinal obstruction, peritoneal effusion, and bleeding. Quality of life (QOL) was evaluated by questionnaires. RESULTS: The subjects of this study were 60 patients, randomly divided into a SA group (n = 30) and a CA group (n = 30). There were no differences in anastomotic healing conditions (P = 1.00). The stent procedure was associated with a significantly shorter anastomosis time than the hand-sewn anastomosis (13.517 ± 4.281 vs. 20.333 ± 2.998 min, respectively; P < 0.001). There were no significant differences in anastomotic leakage, intestinal obstruction, peritoneal effusion, or bleeding between the groups. Questionnaires revealed almost no discrepancy between baseline QOL scores and those assessed 2, 4, 8, 12, and 24 weeks postoperatively in either group. CONCLUSIONS: Intestinal anastomosis with a stent is a non-inferior strategy for laparoscopic colonic surgery, which requires less time for the anastomosis.
Entities:
Keywords:
A novel stent; Intestinal anastomosis; Laparoscopic colonic operation
Authors: L C Capitán Morales; E Rodríguez Nuñez; S Morales Conde; F Sanchez Ganfornina; F D Del Rio Lafuente; E Cabot Ostos; J M Ortega Beviá; J Loscertales Abril; J Cantillana Martínez Journal: Hepatogastroenterology Date: 2000 Sep-Oct
Authors: G Galizia; E Lieto; P Castellano; L Pelosio; V Imperatore; F Canfora; C Pignatelli Journal: Int J Colorectal Dis Date: 1999-12 Impact factor: 2.571